Latest Review Date: July 2024

Category: Medicine   

POLICY:

Comprehensive gait analysis may be considered medically necessary as an aid in surgical planning in patients with gait disorders associated with cerebral palsy.

Comprehensive gait analysis is considered investigational for all other applications including but not limited to:

• Surgical planning for conditions other than gait disorders associated with cerebral palsy.
• Postoperative evaluation of surgical outcomes and rehabilitation planning and/or evaluation for all conditions.

Gait analysis that is not comprehensive is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Gait analysis (GA) is the quantitative laboratory assessment of coordinated muscle function, typically requiring a dedicated facility and staff and analysis of a video recorded observation of a patient walking. Gait analysis has been proposed as an aid in surgical planning, primarily for children with cerebral palsy (CP). It is also a potential tool to help plan rehabilitative strategies for ambulatory problems related to cerebral palsy, aging, stroke, spinal cord injury and other conditions.

Gait analysis is the quantitative assessment of coordinated muscle function; evaluation is conducted in a laboratory and typically involves a dedicated facility and staff. A visual assessment of walking is supplemented by video recording. Videos can be observed from several visual planes at slow speed, allowing detection of movements not observable at normal speed. Joint angles and various time-distance variables, including step length, stride length, cadence, and cycle time, can be measured. Electromyography (EMG), assessed during walking, measures timing and intensity of muscle contractions. This calculation allows determination of whether a certain muscle’s activity is normal, out of phase, continuous, or clonic.

Kinematics is the term used to describe movements of joints and limbs such as angular displacement of joints and angular velocities and accelerations of limb segments. The central element of kinematic assessment is some type of marker system that is used to represent anatomic landmarks, which are then visualized and quantitatively assessed by videotaped observations or optoelectronic data. Movement data are compiled by computer from cameras oriented in several planes, and the movement data are processed so that the motion of joints and limbs can be assessed in three dimensions. The range and direction of motion of a particular joint can be isolated from all the other simultaneous motions that are occurring during walking. Graphic plots of individual joint and limb motion as a function of gait phase can be generated.

Inertial and magnetic measurement systems (IMMSs) are under investigation for the assessment of joints and limbs in three dimensions. Rather than videotaped or optoelectronic calibration of markers placed on anatomic landmarks, IMMS systems involve sensor units that are comprised of miniaturized three-dimensional accelerometers, gyroscopes, and magnetometers that are attached to body segments. The three-dimensional orientation of each sensor is measured in relationship to an earth-based coordinate system through the use of computerized algorithms. One protocol, the “Outwalk” protocol, has been developed to allow the use of an IMMS system for gait analysis.

Gait analysis has been proposed as an aid in surgical planning, primarily for cerebral palsy but also for other conditions such as clubfoot. In addition, it is being investigated as a means to plan rehabilitative strategies (i.e., orthotic-prosthetic devices) for ambulatory problems related to cerebral palsy, aging, stroke, spinal cord injury, etc.

A non-profit organization established in 1997, the Commission for Motion Laboratory Accreditation evaluates and accredits motion laboratories within clinical facilities. A multidisciplinary team uses a set of criteria to evaluate laboratories in the areas of administration (e.g., staffing, policies and procedures), equipment (e.g., accuracy and precision), and data management and reporting (e.g., control and clinical data sets).

KEY POINTS:

Most recently, the policy was updated with reference search through July 11, 2024.

Summary of Evidence

Gait analysis is the quantitative assessment of coordinated muscle function. For patients with cerebral palsy undergoing surgery for gait disorders, one randomized controlled trial did not find improvement in health outcomes for patients who received gait analysis as part of surgical planning, and one non-randomized controlled trial did not find improvement in utilization parameters.  Several studies conducted among patients with CP and other conditions suggest that gait analysis recommendations impact treatment decisions, but the impact of these decisions on health outcomes is as yet unknown. Based on input from clinical reviewers, gait analysis, when comprehensive, may be medically necessary for planning prior to surgery in children with gait disorders associated with cerebral palsy. Due to insufficient evidence, gait analysis is considered investigational for all other indications.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence (NICE)

In 2012, NICE published guidance on the spasticity in children and young people with non-progressive brain disorders. The NICE Guideline was updated in November 2016 and reaffirmed that the decision to perform orthopedic surgery to improve gait should be informed by a thorough pre-operative functional assessment, preferably including gait analysis.

National Institute of Neurological Disorders and Stroke (NINDS)

NINDS summarizes treatment options for cerebral palsy that note orthopedic surgery as a recommended treatment modality when spasticity and stiffness are severe enough to make walking and moving about difficult or painful. Surgical procedures may include lengthening of muscles and tendons to improve mobility and lessen pain. Tendon surgery may help the symptoms for some children with cerebral palsy but may also have adverse long-term consequences. The orthopedic surgeries may be staggered at times appropriate to a child’s age and level of motor development. Surgery may also be performed to correct or greatly improve spinal deformities in people with CP. Surgery may not be indicated for all gait abnormalities and the surgeon may require a quantitative gait analysis before surgery (NINDS, 2020).

KEY WORDS:

Dynamic EMG, Electrodynagram, Gait Analysis, Motion Analysis, Surface EMG

APPROVED BY GOVERNING BODIES:

In May 2003, the Peak Motus Motion Measurement System (Peak Performance Technologies) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. This system uses off-the-shelf video cameras and sensors and proprietary software to document human movement in two- or three-dimensional space. The FDA determined that this device was substantially equivalent to existing devices and is indicated for assessment and training of limb or body motion in gait analysis, pre- or post-rehabilitation evaluation, physical therapy, and similar applications.

In January 2004, the Coda cx1 Motion Analysis System (Charnwood Dynamics, Ltd., Rothley, Leicestershire, UK), was cleared for marketing by FDA through the 510(k) process. The system uses infrared light sight sensors and software data analysis to measure the 3-dimensional movement of patients. FDA determined that the device was substantially equivalent to existing devices and is indicated for analysis of the 3-dimensional motion of the limbs and body of patients who have some impairment of movement functions due to a neurologic or orthopedic cause.

Since 2004, the FDA has cleared other systems for marketing (e.g., SMART-D, Qualisys Clinical System, Vicon Motion Systems). Refer to the FDA website for the complete updated list of systems.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

These codes identify specific components of gait analysis:

REFERENCES:

1. Asay JL, Boyer KA, Andriacchi TP. Repeatability of gait analysis for measuring knee osteoarthritis pain in patients with severe chronic pain. J Orthop Res 2013; 31(7):1007-12.
2. Barkoudah E, Glader L. Cerebral palsy: Treatment of spasticity, dystonia, and associated orthopedic issues. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA.  Topic last updated Dec 06, 2022. 
3. Benedetti MG, Merlo A, Leardini A. Inter-laboratory consistency of gait analysis measurements. Gait Posture 2013; 38(4):934-9.
4. Blue Cross Blue Shield Association.  Gait analysis for pediatric cerebral palsy.  Technology Evaluation Criteria (TEC) Assessment 2001; Volume 16, Tab 19. 
5. Cimolin V, Galli M, Vimercati SL et al. Use of the Gait Deviation Index for the assessment of gastrocnemius fascia lengthening in children with cerebral palsy. Res Dev Disabil 2011; 32(1): 377-81.
6. Cutti A, Ferrari A, Garofalo P et al. ‘Outwalk’: a protocol for clinical gait analysis based on inertial and magnetic sensors. Med Biol Eng Comput 2010; 48(1):17-25.
7. Dobson F, Morris ME, Baker R, et al.  Gait classification in children with cerebral palsy: A systematic review.  Gait Posture 2007; 25(1):140-52.
8. Dugan EL, Shilt JS. The Role of Motion Analysis in Surgical Planning for Gait Abnormalities in Cerebral Palsy. Phys Med Rehabil Clin N Am. 2020;31(1):107–115.
9. Effects of walking analysis on surgical outcomes. Sponsored by the Agency for Healthcare Research and Quality (AHRQ). Last updated July 18, 2012. Available online at ClinicalTrials.gov. 
10. Ferrarello F, Bianchi VA, Baccini M et al. Tools for observational gait analysis in patients with stroke: a systematic review. Phys Ther 2013; 93(12):1673-85.
11. Gough M and Shortland AP.  Can clinical gait analysis guide the management of ambulant children with bilateral spastic cerebral palsy?  J Pediatr Orthop 2008; 28(8):879-83.
12. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
13. Khouri N, Desailly E. Contribution of clinical gait analysis to single-event multi-level surgery in children with cerebral palsy. Orthop Traumatol Surg Res. 2017 Feb;103(1S):S105-S111.
14. Lofterod B, Terjesen T, Skaaret I, et al.  Preoperative gait analysis has a substantial effect on orthopedic decision making in children with cerebral palsy:  Comparison between clinical evaluation and gait analysis in 60 patients.  Acta Orthop 2007; 78(1):74-80.
15. Lofterod B and Terjesen T.  Results of treatment when orthopaedic surgeons follow gait-analysis recommendations in children with CP.  Dev Med Child Neurol 2008; 50(7):503-9.
16. McGinley JL, Baker R, Wolfe R et al. The reliability of three-dimensional kinematic gait measurements: a systematic review. Gait Posture 2009; 29(3):360-9.
17. National Institute for Health and Care Excellence (NICE). Spasticity in children and young people with non-progressive brain disorders (CG145). July 2012, updated November 2016. Available at www.nice.org.uk
18. NINDS cerebral palsy information page. Cerebral Palsy: Hope Through Research. National Institute of Neurological Disorders and Stroke (NINDS). Bethesda, MD: NINDS, National Institutes of Health (NIH). July 2013. Last modified 2023. Available at www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/CerebralPalsy-Hope-Through-Research#3104_21
19. Noonan KJ, Halliday S, Browne R, et al.  Interobserver variability of gait analysis in patients with cerebral palsy.  J Pediatr Orthop 2003; 23(3):279-87.
20. Outcomes of orthopedic surgery using gait laboratory versus observational gait analysis in children with cerebral palsy. Sponsored by the Hospital for Sick Children. Last updated March 26, 2010. Available online at ClinicalTrials.gov. 
21. Rasmussen HM, Pedersen NW, Overgaard S, et al. Gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol. Oct 2019; 61(10):1189-1195.
22. Sankar WN, Rethlefsen SA, Weiss J, et al.  The recurrent clubfoot: can gait analysis help us make better preoperative decisions?  Clin Orthop Relat Res 2009; 467(5):1214-22.
23. Schwartz MH, Rozumalski A, Truong W et al. Predicting the outcome of intramuscular psoas lengthening in children with cerebral palsy using preoperative gait data and the random forest algorithm. Gait Posture 2013; 37(4):473-9.
24. Schwenk M, Howe C, Saleh A et al. Frailty and technology: a systematic review of gait analysis in those with frailty. Gerontology 2014; 60(1):79-89.
25. States RA, Krzak JJ, Salem Y, et al. Instrumented gait analysis for management of gait disorders in children with cerebral palsy: A scoping review. Gait Posture. 2021 Oct;90:1-8.
26. Suda Y, Saitou M, Shibasaki K, et al.  Gait analysis of patients with neurogenic intermittent claudication.  Spine 2002; 27(22):2509-13.
27. van den Noort JC, Ferrari A, Cutti AG et al. Gait analysis in children with cerebral palsy via inertial and magnetic sensors. Med Biol Eng Comput 2013; 51(4):377-86.
28. Wren TA, Gorton GE, Ounpuu S et al. Efficacy of clinical gait analysis: a systematic review. Gait Posture 2011; 34(2):149-53.
29. Wren TA, Kalisvaart MM, Ghatan CE et al. Effects of preoperative gait analysis on costs and amount of surgery. J Pediatr Orthop 2009; 29(6):558-63.
30. Wren TA, Lening C, Rethlefsen SA et al. Impact of gait analysis on correction of excessive hip internal rotation in ambulatory children with cerebral palsy: a randomized controlled trial. Dev Med Child Neurol 2013; 55(10):919-25.
31. Wren TA, Otsuka NY, Bowen RE et al. Outcomes of lower extremity orthopedic surgery in ambulatory children with cerebral palsy with and without gait analysis: Results of a randomized controlled trial. Gait Posture 2013; 38(2):236-41.
32. Wren TA, Woolf K and Kay RM.  How closely do surgeons follow gait analysis recommendations and why?  J Pediatr Orthop B 2005; 14(3):202-5.

POLICY HISTORY:

Medical Policy Group, February 2010 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 23-April 8, 2010

Medical Policy Group, March 2011

Medical Policy Administration Committee, March 2011

Available for comment April 4 – May 18, 2011

Medical Policy Group, February 2012 (2): 2012 Updates; Key Points, References

Medical Policy Group, December 2012 (3): 2013 Coding Updates: Verbiage change to Code 96004-added “or other qualified health care professional”.

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3):  2013 Updates to Key Points and References; no change in policy statement

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (3):  2014 Updates to Description, Key Points, Governing Bodies & References; no change in policy statement.

Medical Policy Group, October 2019 (3): 2019 Updates to Key Points. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, July 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “not medically necessary.” A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, August 2022 (3): 2022 Updates to Key Points and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, July 2023 (11): 2023 Updates to Key Points, Benefit Application and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

Medical Policy Group, July 2024 (11): Updates to Description, Key Points, Approved by Governing Bodies, and References. A peer reviewed literature analysis was completed and no new information was identified that would alter the coverage statement of this policy.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.